ATGAM PACKAGE INSERT PDF

ATGAM is the purified, concentrated and sterile gamma globulin, primarily During processing, the drug is adsorbed with human erythrocyte stroma and with . Globulin [Equine] Sterile Solution. Brand Name Equivalent: Atgam® Product Insert “Preservative Information” indicates that this product does not contain. Brand names: Atgam, Lymphoglobuline, Thymogam up ↑ Antithymocyte globulin, horse ATG (Atgam) package insert (locally hosted backup).

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Antithymocyte globulin, horse ATG (Atgam) | – A Hematology Oncology Wiki

Do not use highly acidic infusion solutions since these solutions may contribute to physical instability over time. The maternal and fetal deaths were attributed to maternal anemia due to red blood cell antigen that humans do not share.

Due to the small sample size, the difference between the ATGAM group and the control group in functional graft survival rate did not achieve statistical significance. Musculoskeletal and connective tissue disorders: Allocation to treatment group was based on the availability of mismatched bone marrow donors.

To identify those at greatest risk of systemic anaphylaxis, skin testing potential recipients insery strongly recommended before commencing treatment. Blood and lymphatic system disorders: Because ATGAM is made from equine and human blood components, it may carry a risk of transmitting infectious agents, e.

Clinical signs associated with anaphylaxis, other infusion associated reactions, and serum sickness have been reported. Study 3 A total of 53 patients 3 to 76 years of age participated in this randomized, placebo-controlled, double-blind study to determine if androgens add to the efficacy of ATGAM in providing favorable hematologic response rates in patients with moderate to severe aplastic anemia. Patient survival rates insdrt similar in the two treatment groups.

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Study 2 was a randomized controlled trial conducted at five different transplant centers. The predictive value of this test has not been proven clinically.

Inform patients that ATGAM may cause serious allergic reactions, infection or abnormal liver or renal function. Transplant Proc ; 13 1: Kidney enlargement, Kidney rupture, Renal failure acute.

HIGHLIGHTS OF PRESCRIBING INFORMATION

Always keep appropriate resuscitation equipment at the patient’s bedside while ATGAM is being administered. Hepatitis viral, Localized infection, Systemic infection. ATGAM is a transparent to slightly opalescent aqueous protein solution. In the presence of a locally positive skin test to ATGAM, serious consideration to alternative forms of therapy should be given. ATGAM treatment was not associated with male or female hormonal or copulation behavior changes.

A total of 42 patients, ages 1 to 69 years were treated. Previously masked reactions pacakge ATGAM may appear when the dose of corticosteroids and other immunosuppressants is being reduced.

The most commonly reported adverse events were rash, fever, arthralgias, chills, headache, myalgia and pruritus. ATGAM is used with concomitant immunosuppressants. Surgery ; 80 2: Because thrombocytopenia can be associated with the administration of ATGAM, patients receiving it for the treatment of aplastic anemia may need prophylactic platelet transfusions to maintain platelets at clinically acceptable levels.

ATGAM is indicated for the management of allograft rejection in renal transplant patients; when administered with conventional therapy at the time of rejection ATGAM increases the frequency of resolution of the acute rejection episode [see Clinical Studies In embryo-fetal toxicity studies, ATGAM was administered to rats and cynomolgus monkeys for 11 and 16 days, respectively during organogenesis.

Additional alternate-day therapy up to paxkage total of 21 doses may be given. A systemic reaction such as a isert rash, tachycardia, dyspnea, hypotension, or anaphylaxis precludes any atgan administration of ATGAM.

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Read the result at 10 minutes: The effectiveness of the ATGAM therapy in the studies described below was evaluated by the hematological response and survival rates Table 3. Transplantation ; 28 4: Adverse reactions in both groups were comparable and included rash, chills, gastrointestinal disturbances, and joint pain during ATGAM infusion, as well as symptoms of serum sickness in all patients.

Five patients had asymptomatic sinus bradycardia; six patients required antihypertensive therapy. Dyskinesia, Syncope, Tremor Cardiac disorders: Observe the patient continuously for possible allergic reactions throughout the infusions [see Warnings and Precautions 5.

Patients were enrolled at the time of first rejection episode and atagm among three treatment groups: Efficacy was evaluated as sustained improvement in peripheral blood counts within 3 months of entry into the study. Confusional state, Disorientation Nervous system disorders: Reversal of acute renal allograft rejection with adjunctive ATG therapy. Before release for clinical use, each lot of ATGAM is tested to assure its ability to inhibit rosette formation between human peripheral lymphocytes and sheep red blood cells in vitro.

Skin Testing To identify those at greatest risk of systemic anaphylaxis, skin testing potential recipients is strongly recommended before commencing treatment. Monitor patients for concurrent infection.

Flank pain, Muscle rigidity, Myalgia, Pain in extremity Renal and urinary disorders: All infections suspected by a physician possibly to have been transmitted by this product should be reported by the physician or other healthcare provider to Pfizer, Inc.